Research Center: Baylor College of Medicine
Location: Jamail Specialty Care Center, 1977 Butler Blvd, Houston TX 77030
Lead Researcher: Sanjay J. Mathew, M.D.
IRB: This study has been reviewed and approved by the Advarra IRB and Baylor College of Medicine Institutional Review Board
About the Study
Did you know that 6.8 million people are currently navigating life with Generalized Anxiety Disorder (GAD)? As the most prevalent mental health challenge in the U.S., anxiety casts a significant shadow, affecting everything from work performance to personal relationships and even physical well-being.
Despite its widespread impact, it’s disheartening that no new treatments for GAD have been approved in over a decade. This study is a beacon of hope, contributing to groundbreaking research aiming to enhance care for GAD. But, here’s the crucial part: Researchers need your help. If you’re someone living with anxiety and have yet to explore therapy or medications, we invite you to be a part of this journey. Your participation could involve testing a potential new medication, and offering hope for symptom relief. If this resonates with you, consider joining the study – your contribution could make a monumental difference for others, just like you!
- Participants could receive a new potential treatment for GAD at no cost.
- Participants will be compensated up to $1072 for participating in this study. Compensation will only be provided to eligible participants at the end of each visit.
- Participants may experience improvements in symptoms related to GAD.
- Participants will be contributing valuable information that may benefit those with Generalized Anxiety Disorder in the future.
- Participants will be helping to advance medical research.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Individuals aged 18-65 who have been diagnosed with GAD
- Must be willing to use effective means of contraception or remain sexually abstinent throughout the duration of this study
- Must be able and willing to abstain from using alcohol, marijuana (including any of its derivatives) and/or any other recreational substances for the duration of the study
- Must not have participated in cognitive behavioral therapy or any other non-pharmacological therapy in the last 3 months
- Must not have participated in an interventional clinical trial (except COVID-19 investigational vaccine trial) in the past 3 months
- Must not have an active cancer requiring current or planned oncologic therapy
- Must not have been diagnosed with COVID-19 within the past 30 days
- Must not have continuing symptoms after COVID-19 that affect thinking, emotions, or nervous system
- Must not be experiencing ongoing, long-term COVID-related issues
- Must be able to attend 5 in person study visits at the research site, and 8 remote visits over approximately 14 weeks
More Study Details
The study team will explain the research in its entirety but some details are:
- Participants will initially be asked to answer qualifying questions. Study staff will ask questions to see if they are eligible, based on specific study requirements. After the end of the screening period, if the results of the tests and procedures show that they qualify to be in this study, and if they agree to take part, they will be randomly assigned to receive ENX-102 or a placebo. The study medication will be given to them to take once daily in the evening by mouth. This decision is made by a computer program, and it will be random, like flipping a coin.
- Study staff will ask several questions to determine how participants feel and to know more about specific symptoms of GAD. Some of these assessments will be audio-recorded during the study. An iPhone will be provided to participants to be used for the following:
- They will be asked to complete an assessment twice daily.
- One evening per week, they will be asked how satisfied they are with the study medication.
- They will return the iPhone at their last clinic visit.
- During the screening period, on the first day of the study treatment period, and at the first day of the follow-up period, you will have a complete physical examination, including your head, neck, eyes, ears, nose, throat, lungs, heart, chest, abdomen, arms, legs, skin, weight, body mass index, and appearance. During the other visits to the study clinic, the physical examination will be shorter, focusing on the appearance, eyes, ears, nose, throat, weight, and body mass index. Health and safety measures including Vital Signs will be measured at all visits to the clinic. This includes your temperature, pulse, blood pressure, and breathing rate while resting. You will also be asked to participate in an ECG, a pregnancy test, an alcohol and drugs test, COVID-19 test, and provide blood and urine samples. Study visits also include self questionnaires as well as assessments with the study staff.
About the Research Center
Baylor College of Medicine
Baylor College of Medicine is a health sciences university that creates knowledge and applies science and discoveries to further education, healthcare and community service locally and globally.
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.